MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number 3058

Device Problems High impedance (1291); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Pain (1994); No Known Impact Or Consequence To Patient (2692)

Event Date 11/13/2017

Event Type  malfunction  

Event Description

Information was received from a consumer regarding a patient who was implanted with a neurostimulator (ins) for urinary dysfunction/sacral nerve stim it was reported that the caller stated that the patient¿s battery longevity seemed like it was extended.Caller stated that the ins had been working well.The patient had the ins for retention and she had not needed to self-catheterize.The patient had some pain in her back and it radiates down both legs.They were interrogating the device to try to determine if the pain could be related.The caller stated that prior to the appointment the patient turned the ins off for 24 hours and then turned stim on again, increased the amplitude.Increasing the stim made the pain better.The caller also stated that when impedance was tested the only pair that was out of range was 0 and 3 at>4000 ohms.The patient also used 0 and 3 for therapy at normally around 3.5v.Caller asked if the battery longevity could be affected by using a pair that had high impedances.It was reviewed with the caller that high impedances would extend the battery longevity.It was also reviewed that high impedances could also decrease the likelihood of getting therapy.[omitted information regarding 8840 issues can be found in (b)(4)].

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information reported that cause of pain was from musculoskeletal.The impedance was high not sure of the cause but clini cal response was excellent.The action taken to resolve the issue was optimized program setting.The patient weight was noted as (b)(6).

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 MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; 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: 7054738
• MDR Text Key: 93569945
• Report Number: 3004209178-2017-24308
• 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: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/19/2018

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: 03/28/2015
• 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: 11/21/2017
• Initial Date FDA Received: 11/22/2017
• Supplement Dates Manufacturer Received: 12/28/2017; 01/19/2018
• Supplement Dates FDA Received: 01/10/2018; 01/19/2018
• Date Device Manufactured: 10/03/2013
• 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: 38 YR
• Patient Weight: 98