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 Therapeutic Effects, Unexpected (2099)

Event Date 01/06/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: a510, serial#: unknown, product type: software, 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).In an intra-operative procedure caller reported that impedance have exclamation point but didn't check actual numerical values.Lead was removed from ins, wiped off and reinserted and amplitude was increased for impedance measurement with no resolution.The rep ensured that the ins was in the pocket.Technical services (tss) had caller rerun impedances on the call - they initially had difficulty communicating with ins but through re-positioning of the communicator were able to connect with the ins.Caller provided results below: default settings - contacts 1, 2, 3 are green (1100-1400 ohms) but contact 0 pairs are all greater than 4k ohms 1.5v, 300 pw - c-3, c-2 less than 50; 0-2, 0-3 greater than 4k; other pairs 1300-2400 ohms 2.0, 360 pw - 0-2 greater than 4k, c-2 less than 50; 1 and 3 contacts are 1500-1900 ohms.Default settings - same as initial measurement - contact 0 pairs greater than 4kohms.Rep stated that throughout the case, patient didn't have motor response but felt stim vaginally at very low amplitudes (less than 2v) on all contacts.Hcp indicated there was no issue with initially inserting the lead and they can see blue tip at the end.Tss reviewed there is less concern with the unipolar pairs being less than 50 ohms as the case isn't used for interstim programming.Tss reviewed motor testing will likely not be beneficial given patient's lack of motor response during the case.Tss reviewed contact 0 appears to be getting current through since patient felt stim on it earlier so hopefully impedances will normalize, otherwise they may only be able to program on contacts 1, 2 and 3.There were no further patient complications are anticipated or expected as a result of this event.

Manufacturer Narrative

Product id a510, serial# unknown.Product type software.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the manufacturer representative (rep).The manufacturer representative stated that the root cause was unknown and that the issue was resolved using a new ins.No further complications were reported.

• 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: 9613401
• MDR Text Key: 176684827
• Report Number: 3004209178-2020-01502
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2020
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/21/2020
• Date Device Manufactured: 03/11/2019
• 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: 73 YR