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

Model Number 3058

Device Problem Unable to Obtain Readings (1516)

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

Event Date 01/05/2019

Event Type  Injury  

Manufacturer Narrative

The ins was not returned as it is still implanted, but the lead was returned.Concomitant medical prodcuts: product id: 3889-28, lot# va1dtar, implanted: (b)(6) 2017, explanted: (b)(6) 2019, product type: lead.Other relevant device(s) are: product id: 3889-28, serial/lot #: va1dtar, ubd: 12-jan-2021, (b)(4).Reference mfr report# 3004209178-2019-01930 for the other ins involved in this event.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) via a manufacturer¿s representative (rep) regarding a patient who was impl anted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.It was reported that the ins was showing out of range impedances on the day of surgery.It was reported that the battery intra-operatively showed ¿unable to read ???¿ once connected to a new battery.It was reported that a revision resolved the reported issue and the lead and ins were both replaced.No patient symptoms were reported.No further complications were reported.

Manufacturer Narrative

Analysis of the lead (va1dtar) revealed a broken conductor from overstress/damage.(b)(4).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 woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 8285570
• MDR Text Key: 134358252
• Report Number: 3004209178-2019-01931
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/13/2019

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: 04/28/2020
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 01/23/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2019
• Initial Date FDA Received: 01/29/2019
• Supplement Dates Manufacturer Received: 05/14/2019; 08/13/2019
• Supplement Dates FDA Received: 06/11/2019; 08/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2018
• 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: 71 YR