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

Model Number 3058

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Low impedance (2285); Electromagnetic Compatibility Problem (2927)

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

Event Date 06/23/2017

Event Type  Injury  

Event Description

Information was received from a company representative regarding a patient who was implanted with a neurostimulator for gastrointestinal/pelvic floor.It was reported that the device was implanted (b)(6) 2016 and the battery longevity was 1-6 months.Patient was programmed on 3- and 0+.Patient was running therapy at 1.7v which had a short.Rep stated this was likely caused of premature battery calculation.Patient was switched to current program 3 months ago and she reported good relief.Rep thought tens unit running while impedance test was done might affect impedance thus he wanted to try again and call back.It was noted the impedance read: c<(>&<)>0 361 ohms c <(>&<)>1 1063 c<(>&<)>2 704 c3 349 c0<(>&<)>1 1063 c0<(>&<)>2 1063 c0<(>&<)>3 <(><<)>50 c1<(>&<)>2 109 c1<(>&<)>3 1063 c2 <(>&<)>3 1063.There were no further complications that have been reported as a result of this event.

Manufacturer Narrative

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

Event Description

Additional information was received from a manufacturer representative (rep).It was reported that the patient left before the rep got back into the room, so they didn't have a chance to re-evaluate their device with the tens device turned off.The patient was coming back at the end of july, when the rep would get a chance to re-evaluate.

Manufacturer Narrative

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

Event Description

Additional information was received from a manufacturer¿s representative stating there was a short on 0 3.There was no known activity or event that prompted the issue.The caller was going to program around out of range combination.No symptoms were reported.No further complications were reported.

Manufacturer Narrative

The main component of the system and other applicable components are: product id 3889-28 lot# va1558m implanted:(b)(6) 2016- explanted: (b)(6)2017 product type lead if information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the manufacturer¿s representative stating that the patient¿s lead was found to have a short and was replaced.No patient symptoms were reported.No further complications were reported.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

Additional information was received.There was no reason discovered for cause of the short.No further information reported.

Manufacturer Narrative

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

Event Description

Additional information was received.Manufacturer representative reported the impedance on the 0/3 pairing only resolved upon increasing amplitude to 1.4v and pulse to 330 as previously instructed to do.Patient did have their tens unit off as well.No further information reported.

• 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 PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6671861
• MDR Text Key: 78584665
• Report Number: 3004209178-2017-13854
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00613994913654
• UDI-Public: 00613994913654
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2017
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/23/2017
• Initial Date FDA Received: 06/27/2017
• Supplement Dates Manufacturer Received: 06/27/2017; 07/25/2017; 07/27/2017; 08/25/2017; 08/25/2017; 08/29/2017
• Supplement Dates FDA Received: 07/17/2017; 07/27/2017; 08/14/2017; 08/29/2017; 09/07/2017; 09/11/2017
• Date Device Manufactured: 04/04/2016
• 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 Outcome(s): Required Intervention
• Patient Age: 72 YR