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

Model Number 3058

Device Problems Break (1069); Unable to Obtain Readings (1516)

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

Event Type  malfunction  

Event Description

It was reported that manufacturer representative was in a case where the lead was functional using a j hook.When the neurostimulator (ins) was plugged in the 0 electrode had impedance issues and the health care provider (hcp) had requested a different ins as he felt there was something up with the set screw.It was reported that hcp had already removed the lead, cleaned it off and reinserted -at least one time.It was reviewed that the proximal end of that lead could get damaged with too much manipulation.The manufacturer representative was on his way to get a second ins.It later reported the ins was changed and reconnected but still getting elevated.The reporter ran check at 1.5v and 300 and then at 2.0 and 360 and getting elevated values,at 1.5v getting between 2200- 2900 and a few questions and at 2v getting in the 3000s.It was reported when he ran 0, 1 and cycled, got motor and sensory at 2v.He ran all case combinations and got motor/sensory between 0.4v and 1.2v.The hcp was concerned the wire was nicked.It was later reported a day later that the temperature was within range but had a couple of impedances, getting??? on 3 of 4 case combinations with some of the bipolar being 2200-2800 ohms.It was added that manufacturer representative waited about 30 minutes and programmed and the patient felt appropriately.The impedance checked and found c1 and c2 were??? but c0 and c3 got normal along with most of bipolar got normal around 1100s.The patient was feeling stimulation appropriately.No outcome was reported regarding this event.A further follow-up is being conducted to obtain this information.A follow-up report will be sent if additional information becomes available.This event was also reported under manufacturer report # 3004209178-2015-01640.

Manufacturer Narrative

Concomitant medical products: product id: neu_set_screw, lot# unknown, product type: accessory.Product id: 3058, serial# (b)(4), implanted: (b)(6) 2015, product type: implantable neurostimulator.Product id: 3889-28, lot# va0qhuk, implanted: (b)(6) 2015, product type: lead.Product id: 3037, serial# (b)(4), product type: programmer, patient.Product id: neu_wrench_acc, serial# unknown, product type: accessory.(b)(4).

• 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 NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 4480079
• MDR Text Key: 5348324
• Report Number: 3004209178-2015-01643
• Device Sequence Number: 1
• Product Code: EZW
• 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: Other
• Type of Report: Initial
• Report Date: 01/12/2015

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: 02/28/2016
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/12/2015
• Initial Date FDA Received: 02/03/2015
• Date Device Manufactured: 09/05/2014
• 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: 00061 YR