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)

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

Event Type  Injury  

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 3889-33, lot# va10r56, implanted: (b)(6) 2016, product type: lead.(b)(4) applies to lead (lot# va10r56) only.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received by a manufacture representative (rep) regarding an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.An impedance check was ran at 3.8 v and 360 pulse width (pw) and the rep said the patient is getting their lead replaced because electrode 3 was greater than 4000 ohms; all other electrodes seemed fine.During the call, the rep inquired about ins status since it showed ok with question marks for longevity; the patient was running stimulation at 3.8 v.A calculation was performed at it showed 15.92 months before end of service (eos).It was reviewed that the ins is very unstable at the end of its life and the device can reset which was why they got the ok and ????.With all of that being said, its up to the healthcare provider (hcp) to decide whether the ins was replaced along with the lead; the ins will be replaced.No patient symptoms and no further complications have been reported as a result of this event.

Manufacturer Narrative

Other applicable components are: product id 3889-33 lot# va10r56 implanted: (b)(6)2016 product type lead if information is provided in the future, a supplemental report will be issued.

Event Description

Additional information from the manufacture representative (rep) on october 27th reported the cause of the high impedances and seeing the ok/??? marks for longevity was unknown.The rep stated the lead was discarded and replaced.It was noted the battery would be returned for analysis.There were no further complications that have been reported as a result of this event.

Manufacturer Narrative

Device returned analysis in progress.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Analysis of ins revealed that returned device passed all functional testing in the laboratory and no anomalies were identified.If information is provided in the future, a supplemental report will be issued.

Event Description

Device was evaluated.

Manufacturer Narrative

Correction to fdr, outdated code submitted.Code updated/corrected 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 woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6983347
• MDR Text Key: 90419234
• Report Number: 3004209178-2017-22636
• 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: 01/05/2018

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/26/2017
• Initial Date FDA Received: 10/27/2017
• Supplement Dates Manufacturer Received: 10/27/2017; 12/15/2017; 12/15/2017; 01/04/2018
• Supplement Dates FDA Received: 10/30/2017; 12/19/2017; 12/20/2017; 01/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2016
• 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