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

Model Number 3058

Device Problems Migration or Expulsion of Device (1395); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Electric Shock (2554)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 978b128, lot#: va2bldw, implanted: (b)(6) 2021, product type: lead.Other relevant device(s) are: product id: 978b128, serial/lot #: (b)(4), ubd: 14-oct-2022, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturer representative regarding a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/ pelvic floor.It was reported that caller reports patient was seen yesterday for her 6 months post implant.Caller reports patient is on program 2: 1-3+ was on 0.4 volts and had increased to 0.5 volts.Caller reports patient's ins battery indicated 13.4 -28.7 months remaining.Caller reports impedance were done and shows green.Suggest at next follow up visit to look at impedance values, not color.No symptoms reported.Additional information was received on 2021-oct-20 from a manufacturer representative (rep).The rep reported that the patient had not been contacted.The rep stated that even though the impedances were 'green' they may be close to out of range, however no values had been recorded.The rep was going to follow up with the patient to see how their symptoms were doing.Additional information received on 2021-12-06 from a manufacturer representative (rep) via patient stated she had an x-ray and was told the lead had moved.They also noted that her stim when turned up caused a jolt.They had since turned their device off and is scheduling for a removal with possible replacement.

Manufacturer Narrative

Concomitant medical products: product id: 978b128, lot#: va2bldw, implanted: (b)(6) 2021, product type: lead.Other relevant device(s) are: product id: 978b128, serial/lot #: (b)(4), ubd: 14-oct-2022, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturer representative regarding a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/ pelvic floor.It was reported that caller reports patient was seen yesterday for her 6 months post implant.Caller reports patient is on program 2: 1-3+ was on 0.4 volts and had increased to 0.5 volts.Caller reports patient's ins battery indicated 13.4 -28.7 months remaining.Caller reports impedance were done and shows green.Suggest at next follow up visit to look at impedance values, not color.No symptoms reported.Additional information was received on 2021-oct-20 from a manufacturer representative (rep).The rep reported that the patient had not been contacted.The rep stated that even though the impedances were 'green' they may be close to out of range, however no values had been recorded.The rep was going to follow up with the patient to see how their symptoms were doing.Additional information received on 2021-12-06 from a manufacturer representative (rep) via patient stated she had an x-ray and was told the lead had moved.They also noted that her stim when turned up caused a jolt.They had since turned their device off and is scheduling for a removal with possible replacement.

• Brand Name: INTERSTIM II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13122665
• MDR Text Key: 285562310
• Report Number: 3004209178-2021-19187
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/30/2021

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: 06/14/2022
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/06/2021
• Initial Date FDA Received: 12/30/2021
• Date Device Manufactured: 12/18/2020
• 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 Sex: Female