MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number 3058

Device Problems High impedance (1291); Unable to Obtain Readings (1516); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/26/2014

Event Type  malfunction  

Event Description

It was reported that during a replacement procedure there were high impedances and a ¿???¿ error.The main issue was with the 0 electrode and there were always abnormal impedances.It was thought that it could have been a set screw issue, but it was found that the set screw was ok and the problem may have been with the lead.Diagnostic testing included impedance testing and reprogramming.Another implantable neurostimulator (ins) was used.There were no patient symptoms or complications associated with the event.Reference mfr.Report #3004209178-2014-17323 for information about the second ins that was used.

Event Description

Follow-up information received from the healthcare provider (hcp) reported that at the implantable neurostimulator (ins) replacement procedure the hcp attempted to place a second lead on the right side.Unfortunately there was an open circuit and it took a considerable amount of time to place the lead, so the hcp elected just to change the ins and attach it to the original lead.The patient recovered without permanent impairment.

Manufacturer Narrative

Product id 3889-28, lot# va0m262; product type lead product id neu_wrench_acc lot# unknown; product type accessory.(b)(4).Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.

Event Description

Additional information received reports that stimulation was felt intra operatively.There was impedance measurements and they all fell out of the normal range.The impedances resolved as soon as they hooked up to the original lead.The patient was receiving effective therapy.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Analysis of the implantable neurostimulator revealed no anomaly.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: INTERSTIM II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 4099924
• MDR Text Key: 4697202
• Report Number: 3004209178-2014-17325
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2016
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/16/2014
• Initial Date FDA Received: 09/18/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided; 10/16/2014
• Supplement Dates FDA Received: 09/23/2014; 10/10/2014; 10/17/2014; 11/10/2014; 09/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/23/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 00076 YR