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

Model Number 3058

Device Problems High impedance (1291); Migration or Expulsion of Device (1395); Unintended Collision (1429); Low Battery (2584)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 12/07/2016

Event Type  Injury  

Manufacturer Narrative

Section d information references the main component of the system and other applicable components are: product id 3889-28 lot# va14qam serial# implanted: (b)(6) 2016 explanted: (b)(6) 2016 product type lead.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer (con) via a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator for urinary incontinence.It was reported that the patient's device worked well for them in the beginning, but, at some point, they lost efficacy.They were seen at the clinic for a battery check and it was noted that the device was at end of service (eos).The patient's sibling stated that the patient had a few falls.Impedances were checked pre-operatively and intra-operatively, which revealed all electrodes were > 4,000.Each electrode was tested and responses were not able to be elicited.X-ray images were taken and it was found that the lead appeared to have migrated.The lead was completely removed and was replaced, and the situation was resolved.

Manufacturer Narrative

Concomitant medical products: product id 3889-28, lot# va14qam, implanted: (b)(6) 2016, explanted: (b)(6) 2016, product type: lead.Analysis results were not available at the time of this report.A follow-up report will be submitted when analysis is completed.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

No new information.

Manufacturer Narrative

Concomitant products: product id: 3889-28, lot# va14qam, implanted: (b)(6) 2016, explanted: (b)(6) 2016, product type: lead.(b)(4).Analysis of the lead (va14qam) found no anomaly.Analysis of the ipg (b)(4) found normal end of life and no telemetry and no output.

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.

• 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 clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6214190
• MDR Text Key: 63590671
• Report Number: 3004209178-2016-27443
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/10/2017

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: 07/28/2017
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/07/2016
• Initial Date FDA Received: 12/29/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 02/09/2017; 02/09/2017
• Supplement Dates FDA Received: 01/23/2017; 02/10/2017; 09/28/2017; 09/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2016
• 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: 83 YR