8870 software application card versions AAA 02, BBB 04, BBC… recallZ-1334-04 · Medtronic Inc, Neurological & Spinal Division · initiated Aug 24, 2004

Why it was recalled

With the Model 8870 software application card versions AAA 02, BBB 04, BBC 02, and BBD 01, which is used in conjunction with the Model 8840 N'Vision Clinician Programmer, users may have mistakenly entered a periodic bolus interval into the minutes field, rather than the hours field, resulting in drug overdoses. This issue is limited to programming the SynchroMed and SynchroMed EL pumps.

FDA root cause category: Other

What the company is doing

Letters were distributed 8/24/2004 utilizing a courier with signed receipt upon delivery. The letters were signed for upon receipt at the consignee address, and the contents of the letter included a response form which can be faxed or mailed back to Medtronic. If any letters are returned as 'undeliverable', attempts will be made to telephone these consignees. A press release was issued on September 22, 2004 by Medtronic Inc. for all Version AAA 02 Model 8870 software application cards in the U.S.

Recall details

Recall number

Z-1334-04

Recall class

Not yet classified by the FDA

Status

Terminated

Initiated by the company

Aug 24, 2004

Posted by the FDA

Sep 23, 2004

Recalling firm

Medtronic Inc, Neurological & Spinal Division

Quantity

3,218 cards distributed in US, plus 1,248 distributed outside of the US

Product code

LKK

FDA submissions

P860004

Distribution

These cards were distributed primarily in the USA, but also to countries in Europe, Middle East and Africa, Canada, Australia, Hong Kong, Latin America and Japan.

Product description

8870 software application card versions AAA 02, BBB 04, BBC 02, and BBD 01, which is used in conjunction with the Model 8840 N''Vision Clinician Programmer.

Other devices under the same FDA submission

51 devices cleared under P860004 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

• SYNCHROMED® II 8637-40

  Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
  1 recall7 deaths4,929 reports
• SYNCHROMED® II 8637-20

  Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
  2 recalls5 deaths4,303 reports
• SYNCHROMED ® II 8637-40

  Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
  1 recall6 deaths4,119 reports
• SYNCHROMED® II 8637-40

  Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
  2 recalls10 deaths3,054 reports
• SYNCHROMED ® II 8637-20

  Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
  1 recall4 deaths3,084 reports
• SYNCHROMED® II 8637-20

  Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
  2 recalls1 death2,588 reports
• SynchroMed® II 8637-40

  Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
  1 recall6 deaths2,291 reports
• SYNCHROMED® II 8637-20

  Medtronic, Inc. · Pump, infusion, implanted, programmable
  1 recall3 deaths2,242 reports
• SYNCHROMED® II 8637-40

  Medtronic, Inc. · Pump, infusion, implanted, programmable
  1 recall4 deaths1,964 reports
• SynchroMed® II 8637-20

  Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
  1 recall4 deaths1,920 reports
• SYNCHROMED™ III 8667-20

  Medtronic, Inc. · Pump, infusion, implanted, programmable
  1 death1,937 reports
• SYNCHROMED ® II 8637-20

  Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
  2 deaths1,766 reports