MAUDE Adverse Event Report: MPRI INTERSTIM; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number 3889-28

Device Problems Break (1069); Peeled/Delaminated (1454); Material Integrity Problem (2978)

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

Event Date 08/16/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturer¿s representative (rep) regarding a trial patient who was using an external neurostimulator (ens).It was reported that when the healthcare provider pulled the boot over the lead, the boot broke and it also caused the insulation coating over the lead to shear back about 1.5 inches.The healthcare provider ended up replacing the lead, the system tested fine.No patient symptoms were reported.No further complications were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a health care professional via a manufacturer representative.It was reported that the insulation sheared back right below where the contacts start, but the cause of this was unknown.The cause of the boot breaking was the doctor trying to get the boot completely over the extension wire.No further patient complications are anticipated or expected as a result of this event.

• Brand Name: INTERSTIM
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7796903
• MDR Text Key: 117582760
• Report Number: 2649622-2018-13569
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00643169864436
• UDI-Public: 00643169864436
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 09/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/12/2022
• Device Model Number: 3889-28
• Device Catalogue Number: 3889-28
• Device Lot Number: VA1SZQ4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/16/2018
• Initial Date FDA Received: 08/20/2018
• Supplement Dates Manufacturer Received: 08/20/2018
• Supplement Dates FDA Received: 09/04/2018
• Date Device Manufactured: 07/12/2018
• 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 Age: 35 YR